Augmentin 500mg/125mg Film-coated Tablets
*Company:
GlaxoSmithKline (Ireland) LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 15 August 2022
File name
ie-spc-augmentintabs500-125mgissue9draft2 eMC.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update of EUCAST Breakpoints
Updated on 04 December 2020
File name
ie-spc-augmentintabs500-125mgissue8draft1-meds.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.4: Update to the warning statement concerning excipients
Section 10: Approval date added
Updated on 04 December 2020
File name
ie-pl-augmentin625mgtabs-issue8draft1-emc.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
Section 2:update to the warning statement reagrding the excipients
Updated on 07 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 March 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Addition of the agreed wording from a PRAC recommendation on Drug Reaction with eosinophilia and systemic symptoms (DRESS) syndrome to:
SmPC Sections 4.4 Special warnings and precautions for use - change to statement: "Serious and occasionally fatal hypersensitivity reactions (including anaphylaxisctoid and severe cutaneous adverse reactions) (including anaphylactoid) reactions have been reported in patients on penicillin therapy."
SmPC 4.8 Undesirable effects: added new adverse effect: drug reaction with eosinophilia and systemic symptoms (DRESS) with a frequency of 'Not known'.
Updated on 06 March 2018
File name
PIL_8337_765.pdf
Reasons for updating
- New PIL for new product
Updated on 06 March 2018
Reasons for updating
- Change to section 6 - date of revision
- Change to section 4 - possible side effects
Updated on 31 October 2017
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to SPC:
Section 4.2 - Update to wording regarding administration with meals.
Section 4.4 - Typographical and grammatical updates.
Section 4.6 - Addition of the sentence "The possibility of sensitisation should be taken into account" in the 'breast-feeding' sub-section (all except for 375 mg tabs)
Section 4.8 - Update to wording regarding administration with meals (UK only, update of MHRA adverse events reporting details)
Section 5.1 - Typographical/grammatical updates
Section 5.2 - Removal of reference to taking medicine at the start of a meal
Section 5.3 - Grammatical correction
Section 6.4 - Grammatical correction
Section 10 - Update of date of revision of the text
Updated on 31 October 2017
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 01 December 2015
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 04 August 2015
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 - Minor administrative/typographical update in line with QRD
Section 4.3 - Minor administrative/typographical update in line with QRD
Section 4.6 - Minor administrative/typographical updates
Section 4.8 - Addition of Reporting of suspected adverse reactions details, formatting
Section 5.1 - Minor administrative/typographical update in line with QRD
Section 6.6 - Minor administrative update in line with QRD
Section 9 - Administrative updates
Section 10 - Update date of revision of text
Updated on 04 August 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 17 July 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 July 2015
Reasons for updating
- Change to date of revision
- Change to MA holder contact details
Updated on 01 July 2014
Reasons for updating
- Change to date of revision
- Addition of manufacturer
Updated on 02 January 2014
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.5 - Interaction with other medicinal products and other forms of interaction,
Section 4.8 - Undesirable effects
Updated on 23 December 2013
Reasons for updating
- Change to side-effects
Updated on 22 August 2013
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.2 Add information on children weighing less than 25 kg
6.1 Name of excipients - update Marcrogol to Macrogol (4000, 6000)
6.3 Update information on desiccated pouch packs
6.5 Harmonise description of packs - rearrange informationo
10 New revision date
Updated on 21 August 2013
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to date of revision
- Change to appearance of the medicine
Updated on 06 April 2011
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
6.5 Nature and contents of container
PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB).
Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets
Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP)
Packs of 14, 20 or 21 tablets
Amber glass bottle
Packs of 30, 50, 100 or 500 tablets
Plastic bottle
Packs of 20, 30 or 100 tablets
Not all pack sizes may be marketed
Updated on 02 November 2010
Reasons for updating
- Change of trade or active ingredient name
- Change due to harmonisation of PIL
Updated on 28 October 2010
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 14 October 2009
Reasons for updating
- Change of inactive ingredient
- Change to date of revision
- Change of special precautions for disposal
Updated on 05 October 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 6 - Pharmaceutical particulars
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
2009 RENEWAL
SUMMARY OF PRODUCT CHARACTERISTICS CHANGES (in red)
1. TRADE NAME OF THE MEDICINAL PRODUCT
Augmentin-Duo Tablets 500mg/125mg Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Amoxicillin Trihydrate equivalent to 500mg Amoxicillin and Potassium Clavulanate equivalent to 125mg clavulanic acid.
For a full list of excipients, see section 6.1
4.2 Posology and Method of Administration
Usual dosages for the treatment of infection
|
Adults and children over 12 years |
For mild to moderate infections one ‘Augmentin-Duo’ Tablet 500/125mg twice a day. Therapy can be started parenterally and continued with an oral preparation. |
Not recommended in children of 12 years and under.
Dosage in renal impairment
Adults:
|
Mild impairment (Creatinine clearance >30 ml/min) |
Moderate impairment (Creatinine clearance 10-30 ml/min) |
Severe impairment (Creatinine clearance <10 ml/min) |
|
No change in dosage |
One ‘Augmentin-Duo’ Tablet 500/125mg 12 hourly |
Not recommended. |
Haemodialysis
Dosage adjustments are based on the maximum recommended level of Amoxicillin. One 500/125mg tablets every 24 hours PLUS one dose during dialysis, to be repeated at the end of dialysis (as serum concentrations of both Amoxicillin and clavulanic acid are decreased).
Dosage in hepatic impairment
Dose with caution; monitor hepatic function at regular intervals. There is as yet insufficient evidence on which to base a dosage recommendation.
Method of administration
To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of co-amoxiclav is optimised when taken at the start of a meal. Duration of therapy should be appropriate and should not exceed 14 days without review. Therapy can be started parenterally and continued with an oral preparation. The tablet should not be broken.
6. PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Tablet Core
Magnesium stearate,
Sodium starch glycollate,
Colloidal anhydrous silica,
Microcrystalline cellulose
Tablet coat
Titanium dioxide (E171),
Hypromellose (Methocel E5 and E15),
Macrogol 4000
Macrogol 6000
Dimeticone.
6.2 Incompatibilities
Not applicable
6.3 Shelf-life
Blister pack - 2 years
Glass bottles: - 3 years
6.4 Special Precautions for Storage
Do not store above 25°C
Store in the original package in order to protect from moisture.
6.5 Nature and Contents of Container
*Blister packs of 10 and 20 tablets in a carton; the blister is comprised of PVC/PVdC with an aluminium overseal.
14 Tablet Pack:
Aluminium PVC/PVdC blisters of 7 tablets enclosed within an aluminium laminate pouch containing a dessicant sachet.
Amber glass bottles containing 6, 30, 50, 100 and 500 tablets, closed with an ROPP cap with pre-inserted wad 2.5g of molecular sieve per 30 tablets as desiccant will be included.
*Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack).
*Perforated cold formed Al/Al blisters (2 plaques of 4 tablets per pack), medical sample pack only.
Not all pack sizes may be marketed
*Packs not marketed.
PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB).
Packs of 4, 10, 12, 16, 20, 24, 30, 100 or 500 tablets
Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch pack (DPP)
Packs of 14, 20 or 21 tablets
Amber glass bottle
Packs of 30, 50, 100 or 500 tablets
Plastic bottle
Packs of 20, 30 or 100 tablets
Not all pack sizes may be marketed
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product.
The tablet should not be broken.
No special requirements
Updated on 24 October 2007
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
3. PHARMACEUTICAL FORM
Film coated tablets
White, oval, film-coated tablets engraved ‘Augmentin’
White to off white oval shaped, film coated tablet debossed with ‘AC’ and a score line on one side and plain on the other side.
6.6 Special precautions for disposal of a used medicinal product or waste materials derived from such medical product and other handling of the product.
Instructions for Use/Handling
The tablet should not be broken.
None
Updated on 23 October 2007
Reasons for updating
- Change to appearance of the medicine
Updated on 20 December 2006
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.5...............
Concomitant use of allopurinol during treatment with amoxicillin can increase the likelihood of allergic skin reactions. There are no data on the concomitant use of amoxicillin-clavulanate and allopurinol.
In common with other antibiotics, amoxicillin-clavulanate may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives....................
4.8...................
Gastrointestinal disorders
Very common Diarrhoea
Common Nausea, vomiting
Nausea is more often associated with higher oral dosages. If gastrointestinal reactions are evident, they may be reduced by taking AUGMENTIN at the start of a meal.
Uncommon Indigestion
Very Rare Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis).
Black hairy tongue
............................
Updated on 26 October 2006
Reasons for updating
- Change to side-effects
Updated on 18 January 2006
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 09 November 2005
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 October 2005
Reasons for updating
- Change to section 6.2 - Incompatibilities
- Change to section 6.3 - Shelf life
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 October 2005
Reasons for updating
- Change to date of revision
Updated on 18 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 09 August 2004
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)